COVID-19 Vaccine Roll Out Update: U.S. and EU

The COVID-19 vaccine rollout isn’t going quite as hoped across the U.S. and the European Union (EU).

President Biden’s new director of the Centers for Disease Control and Prevention (CDC), Rochelle P. Walensky, said over the weekend that the agency doesn’t know how many vaccines are in the U.S., citing the chaos of the recently outgoing Trump administration.

How many vaccine doses actually exist in the U.S. is a perplexing question, as is why the available vaccines are not getting administered. Just over 20 million shots have made it into people’s arms in the U.S., less than half of the amount of vaccines the U.S. government says has been distributed (41.4 million doses).

Vaccine maker Moderna is aware of the current disconnect between vaccines distributed and vaccines administered. The company said in a statement that it had supplied more than 30 million doses to the U.S. government as of Jan. 26, and that just 10.1 million of them had been administered.

The Trump Administration had left distribution to the states, and each state has handled inoculations differently. The Biden administration is hoping to shore up the situation quickly, announcing Tuesday that it was working to buy 200 million more COVID-19 vaccines from both Moderna and Pfizer/BioNTech, the two vaccines that thus far have Emergency Use Authorization (EUA) in the U.S. and in the EU. The goal: to have the entire U.S. population vaccinated by summer’s end.

President Biden has also said he’s committed to 100 million vaccine doses administered in his first 100 days. In recent days, he upped that to 1.5 million shots per day. Biden also wants to increase state funding via a proposed $25 billion package for vaccination manufacturing and distribution. And he’s hoping to open 100 federally funded vaccination sites, as well as mobile units to reach people in remote areas.

Though lagging behind, the U.S. is administering the fifth-most vaccines by population (6.9 of every 100 people), behind Israel (44.9 of every 100 people), the United Arab Emirates (26), the UK (10.4) and Bahrain (8.5), according to Our World in Data.

The vaccine doses Moderna promised the U.S. are still slated to come in on time. The company said that it remains on track to deliver 100 million doses to the U.S. by the end of March, and 200 million doses by the end of June. The U.S. has options with the company for potential purchases of 300 million additional doses.

There are complications to the supply issues. Due to Pfizer/BioNTech vials having one more dose in them than the companies originally thought, the two companies have announced they will be able to supply the U.S. with 200 million doses by the end of May — two months sooner than previously expected. The deadline had been July 31.

In the final days of the Trump administration, Pfizer successfully lobbied the U.S. government to pay it for “extra” doses shipped with its orders that could be turned into additional inoculations by getting six doses from each 5-dose vial.

However, there are limits to how far the dose-stretching strategy can go. Becton Dickinson has contracted with the U.S. government to provide 286 million syringes for COVID-19 vaccines, including 40 million "low dead space" syringes that could stretch supplies of the Pfizer COVID-19 vaccine from five to six doses per vial, but the device company said it can’t immediately produce more of the specialty syringes.

And many states continue to complain that the demand for vaccines is far greater than the available supply. New York Gov. Andrew Cuomo (D) said Monday that vaccine supplies in the state are running low.

“Week after week what we find is, demand for the vaccine and our ability to distribute it quickly outpaces the federal supply. This will continue to happen unless we see an increase to our weekly allocation,” he said.

Pfizer/BioNTech are struggling to meet the outsized demand for their vaccine, the first one to get an EUA in the U.S. Pitching in to help with the volume problem, French vaccine giant Sanofi — which is working on a COVID-19 vaccine with GlaxoSmithKline that got delayed in December due to inadequate results in older adults — said Tuesday that it will fill and pack more than 100 million of doses of Pfizer’s vaccine in an effort to help meet the  demand. This will occur at its German plant in Frankfurt, Germany.

The supply issues are not limited to the U.S. The EU — a 27-country bloc where vaccination against COVID-19 started on Dec. 27 — has hit a rough patch on COVID-19 vaccinations.

AstraZeneca shocked EU officials last week when it said its first delivery of its COVID-19 vaccine, developed along with Oxford University, would include a lower volume than originally stated due to manufacturing problems in Europe. The company’s vaccine has been approved in the UK and is expected to be approved in the EU at the end of this month. The company did not specify how much lower the numbers are likely to be. AstraZeneca was slated to deliver up to 400 million doses to the EU.

A week earlier, Pfizer/BioNTech announced that there would be a temporary reduction in its vaccine deliveries to the EU.  As a result, the EU is threatening to restrict the export of COVID-19 vaccines manufactured in the bloc.

Pfizer, which now plans to label its vials as containing 6-doses, is getting pushback on that in Europe, with Sweden’s government reportedly pausing payments because of the contractual change.

But the vaccine drugmakers continue to express optimism about the supply situation. Pfizer told FDAnews, “We believe that we can potentially deliver approximately 2 billion doses worldwide by the end of 2021.” That’s an increase from the previous forecast of up to 1.3 billion doses. — Suz Redfearn and Martin Berman-Gorvine